SLN124
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Product Information
Scientific name: SLN124
Brand name: Ν/Α
RESPONSIBLE: Silence Therapeutics -
Clinical Trial/Study Information <em><sup>Last update: 22/6/2023</sup></em>
Trial Name: GEMINI II
Code: : NCT04718844
Phase: 1b
Eligible patient diagnosis: NTD β-thalassaemia or HbE/ β-thalassaemia (adults)
No. of Patients enrolled: 56 (Last update: 22/6/2023)
Study Sites: 20 Sites per countryAnticipated completion date: September 2023
Scope of the Study / Aim: Evaluation of safety and tolerability (adverse event nature and frequency) of single and multiple doses of SLN124
Update: 20 December 2023
The multiple dose portion of the GEMINI II phase 1 study in non-transfusion dependent thalassemia patients was completed.
SLN124 was well tolerated at all doses with no safety issues identified.
While proof of mechanism has been established in healthy volunteers, the effects on indicators of iron metabolism were variable in this study population of heterogeneous thalassemia subjects.
The company is prioritizing R&D efforts on the ongoing PV program and does not have plans to advance development in thalassemia at this time.
Update: 30 September 2023
- Topline data is on track to be announced in Oct – Dec 2023.
Update: 30 June 2023
- Dosing in the multiple dose portion of the GEMINI II phase 1 study in thalassemia
patients has been completed. - Topline data is on track to be announced in Oct – Dec 2023.
Update: 31 March 2023
Silence expects data from the ongoing phase 1 multiple dose study of SLN124 in thalassemia patients in the fourth quarter of 2023.
In March 2023, the dosing of the multiple dose portion of the GEMINI II phase 1 study of SLN124 in thalassemia patients was completed. Topline data will be announced in the fourth quarter of 2023.
Sources: https://www.businesswire.com/news/home/20230112005311/en/SilenceTherapeutics-Provides-SLN360-and-SLN124-Clinical-Program-Updates
https://www.businesswire.com/news/home/20230315005297/en/SilenceTherapeutics-Reports-Fourth-Quarter-and-Full-Year-2022-Results